EP3733713A4 - BISPECIFIC ANTIBODIES AND ITS APPLICATIONS - Google Patents

BISPECIFIC ANTIBODIES AND ITS APPLICATIONS Download PDF

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Publication number
EP3733713A4
EP3733713A4 EP19776671.0A EP19776671A EP3733713A4 EP 3733713 A4 EP3733713 A4 EP 3733713A4 EP 19776671 A EP19776671 A EP 19776671A EP 3733713 A4 EP3733713 A4 EP 3733713A4
Authority
EP
European Patent Office
Prior art keywords
applications
bispecific antibodies
bispecific
antibodies
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19776671.0A
Other languages
German (de)
French (fr)
Other versions
EP3733713A1 (en
Inventor
Wenjun Zhang
Cuijuan CHEN
Xuemei WEI
Tonghui LUO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Excelmab Inc
Original Assignee
Excelmab Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Excelmab Inc filed Critical Excelmab Inc
Publication of EP3733713A1 publication Critical patent/EP3733713A1/en
Publication of EP3733713A4 publication Critical patent/EP3733713A4/en
Pending legal-status Critical Current

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/468Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/522CH1 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Oncology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Wood Science & Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Microbiology (AREA)
  • Plant Pathology (AREA)
  • Mycology (AREA)
  • Physics & Mathematics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
EP19776671.0A 2018-03-27 2019-01-07 BISPECIFIC ANTIBODIES AND ITS APPLICATIONS Pending EP3733713A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201810263832.0A CN110305217B (en) 2018-03-27 2018-03-27 Bispecific antibodies and their applications
PCT/CN2019/070655 WO2019184549A1 (en) 2018-03-27 2019-01-07 Bispecific antibody and uses thereof

Publications (2)

Publication Number Publication Date
EP3733713A1 EP3733713A1 (en) 2020-11-04
EP3733713A4 true EP3733713A4 (en) 2021-05-26

Family

ID=68062214

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19776671.0A Pending EP3733713A4 (en) 2018-03-27 2019-01-07 BISPECIFIC ANTIBODIES AND ITS APPLICATIONS

Country Status (7)

Country Link
US (1) US11718671B2 (en)
EP (1) EP3733713A4 (en)
JP (1) JP7066953B2 (en)
CN (1) CN110305217B (en)
AU (1) AU2019240974B2 (en)
CA (1) CA3089254C (en)
WO (1) WO2019184549A1 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110551221B (en) * 2019-07-02 2021-03-05 广州爱思迈生物医药科技有限公司 A kind of bispecific antibody and its preparation method and application
KR20220092958A (en) * 2019-11-07 2022-07-04 암젠 인크 High salt wash during cation exchange chromatography to remove product-related impurities
MX2022005593A (en) * 2019-11-07 2022-06-09 Amgen Inc CONDITIONING OF THE CHARGE WITH HIGH SALINITY DURING CATION EXCHANGE CHROMATOGRAPHY TO ELIMINATE RELATED IMPURITIES FROM THE PRODUCT.
CN111748040B (en) * 2020-07-31 2021-09-28 杭州皓阳生物技术有限公司 Multivalent antibodies and methods of making same
JP7853992B2 (en) * 2020-11-10 2026-04-30 上海齊魯制藥研究中心有限公司 Bispecific antibodies against claudin 18A2 and CD3 and their use
CN113527493B (en) * 2021-07-20 2023-10-27 广州爱思迈生物医药科技有限公司 A B7-H3 antibody and its application
JP2024530166A (en) * 2021-08-04 2024-08-16 アブプロ コーポレーション CD3-Targeting Antibodies and Their Uses
CN115109164A (en) * 2022-06-07 2022-09-27 博际生物医药科技(杭州)有限公司 Bispecific antibodies targeting EPCAM and CD3
US20250011420A1 (en) * 2023-07-03 2025-01-09 Medicovestor, Inc. Proteins that bind sp17 including fully-human anti-sp17 antibodies
US12624097B2 (en) 2023-07-03 2026-05-12 Medicovestor, Inc. Nucleic acids, vectors, and cells that encode anti-Sp17 antibodies and other Sp17 binding proteins
WO2025085781A1 (en) 2023-10-19 2025-04-24 Genentech, Inc. Combinations of il15/il15r alpha heterodimeric fc-fusion proteins and her2xcd3 bispecific antibodies for the treatment of her2-positive cancers
US12121587B1 (en) 2023-12-26 2024-10-22 Medicovestor, Inc. Dimeric antibodies

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009055074A2 (en) * 2007-10-25 2009-04-30 Wyeth Erbb2 binding proteins and use thereof
WO2012162067A2 (en) * 2011-05-21 2012-11-29 Macrogenics, Inc. Cd3-binding molecules capable of binding to human and non-human cd3
WO2015016608A1 (en) * 2013-07-31 2015-02-05 삼성전자 주식회사 Composition for carrying nucleic acid, comprising antibody and nucleic acid-binding peptide
CN104829728A (en) * 2015-01-21 2015-08-12 武汉友芝友生物制药有限公司 Construction and application of bispecific antibody HER2*CD3

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US7935531B2 (en) 2000-02-22 2011-05-03 Board Of Trustees Of The University Of Arkansas Methods for the early diagnosis of ovarian cancer
EP2181595A1 (en) 2002-08-16 2010-05-05 Yeda Research And Development Company Ltd. Tumor associated antigen, peptides thereof, and use of same as anti-tumor vaccines
KR101131727B1 (en) 2004-06-11 2012-03-28 가톨릭대학교 산학협력단 DENDRITE CELLS TRANSDUCED WITH RECOMBINANT ADENOVIRUS AdVCEA WHICH GENERATE CEA-SPECIFIC CYTOTOXIC T LYMPHOCYTES, VACCINE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME
EP1748067A1 (en) 2005-07-29 2007-01-31 Institut Pasteur Polynucleotides encoding MHC class I-restricted hTERT epitopes, analogues thereof or polyepitopes
JP5686953B2 (en) 2005-10-11 2015-03-18 アムゲン リサーチ (ミュンヘン) ゲーエムベーハー Compositions comprising cross-species-specific antibodies and uses of the compositions
DK1989224T3 (en) 2006-02-24 2011-02-14 Us Gov Health & Human Serv Immunogenic peptides and methods of use
US8871211B2 (en) 2006-09-28 2014-10-28 Cedars-Sinai Medical Center Cancer vaccines and vaccination methods
WO2008127285A2 (en) 2006-10-05 2008-10-23 The Board Of Trustees Of The University Of Arkansas Target peptides for ovarian cancer immunotherapy
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HUE029925T2 (en) * 2008-04-02 2017-04-28 Macrogenics Inc Her2/neu-specific antibodies and methods of using same
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Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
WO2009055074A2 (en) * 2007-10-25 2009-04-30 Wyeth Erbb2 binding proteins and use thereof
WO2012162067A2 (en) * 2011-05-21 2012-11-29 Macrogenics, Inc. Cd3-binding molecules capable of binding to human and non-human cd3
WO2015016608A1 (en) * 2013-07-31 2015-02-05 삼성전자 주식회사 Composition for carrying nucleic acid, comprising antibody and nucleic acid-binding peptide
CN104829728A (en) * 2015-01-21 2015-08-12 武汉友芝友生物制药有限公司 Construction and application of bispecific antibody HER2*CD3

Non-Patent Citations (2)

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Title
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WUELLNER ULRICH ET AL: "Bispecific CD3/HER2 Targeting FynomAb Induces Redirected T Cell-Mediated Cytolysis with High Potency and Enhanced Tumor Selectivity", ANTIBODIES, vol. 4, no. 4, 8 December 2015 (2015-12-08), pages 426 - 440, XP055795432, DOI: 10.3390/antib4040426 *

Also Published As

Publication number Publication date
JP2021511052A (en) 2021-05-06
EP3733713A1 (en) 2020-11-04
AU2019240974B2 (en) 2022-12-01
CN110305217A (en) 2019-10-08
US20210122823A1 (en) 2021-04-29
CN110305217B (en) 2022-03-29
US11718671B2 (en) 2023-08-08
JP7066953B2 (en) 2022-05-16
CA3089254A1 (en) 2019-10-03
AU2019240974A1 (en) 2020-08-13
WO2019184549A1 (en) 2019-10-03
CA3089254C (en) 2025-06-10

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